BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN RH 130 DEG 11MM X 360MM

    MDR report key: 3781634 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03341
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE IMPLANTED - UNKNOWN. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. (B)(4). PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03341 & 03342).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THE FRACTURE WAS NOT PROPERLY REDUCED DURING THE INITIAL PROCEDURE, WHICH LED TO THE FRACTURE OF THE NAIL. IMPROPER COMPRESSION OF THE FRACTURE AT THE TIME THE NAIL WAS IMPLANTED CONSTITUTES OFF LABEL USE AND THE LIKELY CAUSE OF THE DEVICE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THE FRACTURE WAS NOT PROPERLY REDUCED DURING THE INITIAL PROCEDURE, WHICH LED TO THE FRACTURE OF THE NAIL. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO REMOVE AND REPLACE THE FRACTURED NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260491 HFN RH 130 DEG 11MM X 360MM ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A DMCCGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R